PV 403 Pressure Controlled Ventilation Operating Manual Issue X-1

Table of contents

9

Operating Manual PV 403

Setting the PV 403 PEEP ... 36 9.1 9.2 9.3 9.4 9.5 9.6 9.7 9.8 9.9 9.10 9.11 9.12 9.13 9.14

Locking/unlocking the settings panel ... 36 Selecting the ventilation mode... 37 Setting the pressure ... 37 Setting the rate ... 37 Setting the inspiration time (Insp. Time) ... 38 I/E Ratio table ... 38 Incorrect settings for rate and inspiration time ... 39 Setting the inspiration trigger (Insp. Trig.) ... 39 Setting the plateau... 40 Setting the expiratory trigger (Exp. Trig.) ... 40 Setting the tidal volume ... 41 Incorrect settings for rate and tidal volume ... 41 Setting the PEEP function... 42 Incorrect settings for pressure and PEEP... 42

10 Alarm ... 43 10.1 10.2 10.3 10.4 10.5 10.6 10.7 10.8 10.9 10.10

Audible alarm... 43 Power failure alarm... 43 Alarm for low pressure ... 44 Alarm for high pressure ... 44 Alarm for low tidal volume... 45 Alarm for high rate... 45 Low battery alarm ... 45 Function error alarm ... 46 Setting the alarm levels in PSV and PCV modes ... 46 Setting the alarm levels in VCV mode ... 47

11 Complete function check... 49 11.1 11.2 11.3 11.4 11.5 11.6 11.7 11.8 11.9 11.10 11.11 11.12 11.13

Preparing the function check ... 49 Alarm check – low pressure... 50 Inspiration check ... 50 Exhalation check ... 51 Alarm check – high pressure... 51 Inspiration trigger check ... 51 Expiratory trigger check ... 52 Tidal volume check... 52 Alarm check – low tidal volume ... 52 Alarm check – high rate ... 53 PEEP function check... 53 Power failure check... 53 Completing the function check ... 54

12 Cleaning the PV 403 PEEP and replacing the filters... 55 12.1 12.2 12.3 12.4 12.5 12.6 12.7

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Cleaning/disinfection in the clinic ... 55 Cleaning/disinfection in the home ... 56 Cleaning and replacing the patient air filter... 56 Using a bacteria filter... 57 Cleaning the mask and tubes... 57 Cleaning the BREAS exhalation valve ... 58 Change of patient ... 58

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Operating Manual PV 403

Table of contents

13 Maintenance... 59 13.1 13.2 13.3

Checking the operation hours and software version ... 59 Setting the date and time... 59 Disposal ... 60

14 Troubleshooting ... 61 15 Service... 63 15.1 15.2

Yearly maintenance check ... 63 Service records... 64

16 Technical specifications... 65 16.1 16.2 16.3 16.4

Analog/Digital output connector ... 68 Alarm output connector ... 69 Compliance of Standards ... 71 Delivery settings ... 72

17 Accessories ... 73 18 Patient settings – BREAS PV 403 PEEP... 74 19 Patient instructions – BREAS ventilator PV 403 PEEP... 76

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Table of contents

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Operating Manual PV 403

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Operating Manual PV 403 PEEP

1

Introduction

Introduction The PV 403 PEEP is a pressure-controlled, pressure-support, and volume-controlled ventilator for patients who require continuous or intermittent support by mechanical ventilation. It has three modes of operation: PSV, PCV, and VCV. All modes have an adjustable trigger sensitivity setting which allows the patient to initiate ventilator-assisted breaths. In the PCV mode (Pressure Controlled Ventilation), the ventilator provides assisted or controlled pressure-regulated breathing. In the PSV mode (Pressure Support Ventilation), the ventilator’s expiratory sense can also be adjusted allowing the ventilator to more easily match each patient’s needs. In the VCV mode (Volume Controlled Ventilation), the ventilator provides assisted or controlled volume-regulated breathing. The internal PEEP (Positive End Expiratory Pressure) function is used for controlling the patient’s airway pressure during the exhalation phase. The internal patient data memory of the PV 403 PEEP can be downloaded to a PC, printed out, and analysed via the Patient Data Analysis software package. For more information about this software package, please contact your BREAS representative.

1.1

Intended use The PV 403 PEEP is intended for treatment • in institutions and patients’ homes,

1.2

•

by qualified, trained personnel under the direction of a physician,

•

of adult and pediatric patients with reduced lung function, using either a nasal mask or a trach tube,

•

that may be life-supporting, provided that an internal or external battery back-up source is used and emergency equipment (resuscitation bag) is available.

Contraindications The contraindications for treatment by the PV 403 PEEP could be as follows: • Generally after thoracic surgery, the surgeon has to be consulted to avoid organ damage. •

After heart surgery, care should be taken to choose ventilator parameters which do not adversely affect haemodynamics.

•

In case of facial surgery, the ventilator shall not be used with a nasal mask.

•

After abdominal surgery, cautious use of ventilatory therapy is necessary because of pressure changes transmitted to the abdomen.

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Introduction

1.3

Operating Manual PV 403 PEEP

About this manual Read this manual before setting up and using the PV 403 PEEP to ensure correct usage, maximum performance, and serviceability. This manual is primarily intended for care providers, clinical personnel, doctors and others who require a working knowledge of the PV 403 PEEP. However, the chapter “Patient instructions – BREAS ventilator PV 403 PEEP” on page 76 is intended for the end-user. Service personnel may order the BREAS PV 403 PEEP Service Manual which contains detailed service and repair information, such as technical instructions, calibration data, electrical diagrams, component lists, and so on. It also contains information on the installation and maintenance of accessories.

Icons In this manual, icons are used to alert you to specific information. The meaning of each icon is explained in the table below. Icon

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Type of information

Explanation

Note

A “note” provides information that is not of critical importance, but may nevertheless be valuable, such as tips and tricks.

Warning

A “warning” is used when there is a risk of personal injury or equipment damage. Moreover, it is used when you may risk losing data, getting an unexpected result or having to redo (part of) a procedure.

Reference

A “reference” guides you to other manuals where you will find additional information on a specific topic.

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2

Safety precautions

Safety precautions This chapter lists all safety precautions for the PV 403 PEEP. Furthermore, the safety symbols on the equipment designation label are described.

General •

Do not use the PV 403 PEEP for any other treatment than the intended use recommended by BREAS.

•

Clinic personnel and the end-user must read this operating manual and understand how the PV 403 PEEP is used before setting up and using the apparatus.

•

The PV 403 PEEP may be used for total life support provided that emergency equipment (resuscitation bag) is available and either an external battery and/or an internal back-up battery pack is installed. The battery supply serves as a back-up power supply if the mains power supply fails or is disconnected. For more information, see the chapter “Using a battery supply” on page 23.

•

Adjustment of settings should always be based on medical advice and must be carried out by authorised clinic personnel only. Blood gas measurement shall be performed when changing settings or changing to another device.

•

All the patient alarms of the PV 403 PEEP must be set at safe levels that will effectively warn the user of any incident. The alarm levels should be assessed considering the patient settings and the exact configuration of the patient circuit components. Any change of settings or components may require the readjustment of the alarm levels.

•

Do not use an autoclave to sterilise the PV 403 PEEP.

•

Always perform a function check before use, see page 21.

•

If the PV 403 PEEP is used continuously (24 hours a day), it must be switched off and on again once a day while connected to the power source (mains supply, external battery, or internal battery). This is necessary in order for the PV 403 PEEP to perform a self-test.

•

If the electronics fail, the PV 403 PEEP cannot deliver a pressure higher than 60 mbar at single fault condition.

•

To ensure maximum operational reliability, the PV 403 PEEP must be serviced at the specified intervals by authorised service personnel.

Environmental conditions •

Do not use the PV 403 PEEP in environments where there are explosive gases or other flammable anaesthetic agents present.

•

Do not place the ventilator so that the air inlet at the rear can be blocked.

•

Do not use the PV 403 PEEP when placed in direct sunlight.

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Safety precautions

Operating Manual PV 403 PEEP

•

The performance of the ventilator and the treatment of the patient may deteriorate if the operation conditions are not fulfilled, see the chapter “Technical specifications” on page 65.

•

Do not use the PV 403 PEEP immediately after storage or transport outside the recommended operating conditions.

•

The device complies with the requirements of IEC 601-1-2 with regards to “Electromagnetic compatibility”. Necessary measures must be taken in order to ascertain that the specified limits are not exceeded as this may impair the safety of the ventilator. Such measures should include, but not be limited to: – normal precautions with regard to relative humidity and conductive characteristics of clothing in order to minimise the build-up of electrostatic charges. – avoiding the use of radio emitting devices in close proximity to the equipment, such as high-frequency surgery apparatus or cordless (mobile) telephones, CB radios, microwave ovens, etc. resulting in a field level exceeding 10 V/m. – avoiding the use of patient hoses or tubes made of static or electrically conductive material.

User precautions •

Use a new patient circuit for each new user of the PV 403 PEEP.

•

Patient-connected parts and filter must be replaced regularly to ensure correct function of the PV 403 PEEP. All replaced parts must be disposed of according to local environmental regulations regarding the disposal of used equipment and parts.

•

If the PV 403 PEEP is used in a clinic by several users, a bacteria filter must be fitted between the air outlet and the patient circuit to prevent contamination.

•

Contact your responsible clinic if any of the following symptoms appear: dryness of air passages or nose, skin sensitivity, runny nose, ear pain, sinus discomfort, mood change, disorientation, irritability, or memory lapse.

Use of humidifier •

If a heated humidifier is used together with the PV 403 PEEP, it must comply with the ISO 8185 standard.

•

If a heated humidifier is used, always place the humidifier lower than the patient and the PV 403 PEEP. This prevents the water from causing personal injury or equipment damage when running down if the humidifier tips over.

•

The use of an HME or a heated humidifier may require readjustment of the PV 403 PEEP’s low-pressure alarm.

•

When using a heated humidifier, condensation may form in the patient circuit over time. – Periodically check for moisture in the patient circuit. When present, remove the moisture. Before attempting to dry the circuit, disconnect it from the ventilator. The frequency at which these checks must be performed will depend on the

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Operating Manual PV 403 PEEP

Safety precautions

patient’s own condition and the device used. You should assess this on an individual basis in accordance with the patient’s needs. – If the condensation in the patient circuit is excessive, the use of a heated humidifier may require the installation of a water trap in the circuit. The water trap prevents any condensated water in the patient circuit from running into the patient airways and causing personal injury.

Use of oxygen •

Oxygen must only be supplied through the patient hose using the BREAS oxygen adapter.

•

In some cases, an external pressure limiter may be required when adding supplemental oxygen to the patient circuit. The following precautions must be taken when using oxygen as its presence can speed up the combustion of flammable materials:

•

Naked lights and other sources of ignition must be kept well away from the oxygen cylinder, at least two metres.

•

Do not smoke in a room where oxygen is being used.

•

The room must be well ventilated.

•

Do not use aerosols or solvents close to the oxygen supply, even when switched off.

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Safety precautions

2.1

Operating Manual PV 403 PEEP

Safety symbols The safety symbols are printed on the equipment designation label of the PV 403 PEEP. The equipment designation label and the model/serial number label are located underneath the machine. They are displayed in the figure below.

This table describes the symbols on the model/serial number label and the equipment designation label. No.

Symbol

Explanation

1

–

Model designation

2

–

Serial number

3

Read “Disposal” on page 60 for information about recycling and disposal.

4

Class II equipment; dual isolation

5

Body floating

6

Read the operating manual thoroughly before connecting the PV 403 PEEP to the patient.

7 0123

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CE marking applies according to the directive MDD 93/42/ EEC.

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3

Main components and panels

Main components and panels This chapter gives an overview of the main components and the panels of the PV 403 PEEP. For more information on the settings of the ventilator, see the chapter “Setting the PV 403 PEEP” on page 36.

3.1

Main components The figure below displays the main components of the PV 403 PEEP.

Main components The table below describes the main components of the PV 403 PEEP. No.

Component

Description

1

Front panel

Panel used for connecting PV 403 PEEP to the patient circuit.

2

Settings panel

Panel with user controls, indicator LEDs, and LCD display used for adjusting the patient settings.

3

Rear panel

Panel used for connecting the PV 403 PEEP to the power source and to external equipment.

4

Air inlet and filter cassette

The filter is used for filtering incoming air. For details, see page 55.

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Main components and panels

3.2

Operating Manual PV 403 PEEP

Front panel The front panel of the PV 403 PEEP is shown in the illustration below.

Front connectors The table below describes the connectors of the front of the PV 403 PEEP.

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No.

Connector

Function

1

Patient air outlet

Used for connecting the ventilator to the patient tube. Diameter 22 mm ISO cone, male.

2

Exhalation valve connector

Used for connecting the white control tube to the exhalation valve. Diameter 4 mm tube.

3

Pressure measuring connector

Used for connecting the green pressure tube to the exhalation valve. Diameter 3 mm tube.

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3.3

Main components and panels

Settings panel The user controls and the LEDs on the settings panel that is located on the top of the PV 403 PEEP are shown in the illustration below.

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Main components and panels

Operating Manual PV 403 PEEP

User controls and indicator LEDs The table below describes the user controls and LEDs on the settings panel of the PV 403 PEEP.

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No.

User controls, indicator LEDs

Function

1

Patient pressure meter

Used for displaying the current patient pressure, measured at the exhalation valve.

2

LCD display

Used for controlling various settings and functions of the PV 403 PEEP, see the following table.

3

+/– Setting buttons

User control used for: • checking the voltage of the current power source • locking the settings panel • increasing and decreasing the value of the selected setting parameter • adjusting the alarm levels for low and high pressure, high rate, and low tidal volume • setting the actual date and time

4

Alarm set button

Used for displaying and setting the alarm levels for high and low pressure, high rate, and low tidal volume.

5

Mode button

Used for displaying and setting the active ventilation mode; PCV, PSV, or VCV mode.

6

Muted alarm LED

Indicates that the audible alarm is temporarily muted.

7

Function button

User control used for: • lighting the background illumination of the LCD display • selecting the setting parameters to be adjusted • displaying the actual date and time • muting the audible alarms for low pressure, low tidal volume, and high rate

8

Lock function LED

Used for indicating that the settings panel of the PV 403 PEEP is locked (green light).

9

Alarm indicator panel

Used for activating the alarm settings. The alarm LEDs lights as follows: High priority alarms (red LEDs): • Power – power failure during operation (steady light). • Pressure – the delivered pressure is higher, or lower than the set alarm levels. • Volume – the tidal volume is below the set alarm level. Medium priority alarms (yellow LEDs): • Rate – the breath rate has exceeded the set alarm level. • Battery – the internal battery voltage drops below 23.3 V during operation.

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Main components and panels

No.

User controls, indicator LEDs

Function

10

On/Off button

Used for switching the PV 403 PEEP on or off. LED indicating that the ventilator is switched on and connected to power source: • Steady light – running from mains supply. • Flashing light – running from battery supply.

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Main components and panels

3.4

Operating Manual PV 403 PEEP

LCD display The table below describes the user controls and the corresponding indicator LEDs on the LCD display of the PV 403 PEEP.

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No. User controls and indicator LEDs

Function

A

Pressure

User control used for reading and setting the patient pressure. Left LED indicating inspiration.

B

Rate

User control used for setting and displaying the patient’s breathing rate.

C

Insp. Time

User control used for setting and displaying the inspiration time.

D

Insp. Trig.

Used for setting and displaying the inspiration trigger setting. Left LED indicating that the patient triggers a breath.

E

Plateau

Used for setting and displaying the speed at which the pressure or volume increases to the desired value.

F

Exp. Trig.

Used for setting and displaying the expiratory trigger.

G

Volume

User control used for setting and displaying the delivered tidal volume.

H

Power

User control used for displaying • the current power source: M – mains power, E – external battery, or I – internal battery • the voltage of the current power source Left LED indicating that the PV 403 PEEP is connected to the mains.

I

PEEP

Used for setting and displaying the internal PEEP function.

J

Indicator LEDs

LEDs on the right-hand side of the display that indicate which of the functions listed above is selected when pressing the Function button: • Pressure (mbar) • Rate (BPM) • Inspiration time (Sec) • Inspiration trigger (mbar) • Plateau (–) • Expiratory trigger (%) • Tidal volume (Litre) • PEEP (mbar)

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3.5

Main components and panels

Rear panel The components and the user controls on the rear panel of the PV 403 PEEP are shown in the illustration below.

User controls and components The table below describes the functions of the user controls, the connectors, and other components on the rear panel. No.

User controls and components

Function

1

Mains power socket

Used for connecting the PV 403 PEEP to the mains through the power cord.

2

Alarm output connector

Used for connecting the PV 403 PEEP to an external alarm device. Read the operating manual thoroughly before using the alarm connector, see page 69.

3

Fastening clamp

Used for securing the power cord.

4

Alarm buzzer

Used for the audible alarm of the PV 403 PEEP.

5

Adjust screw for sound level

Used for adjusting the sound level of the audible alarm.

6

Connector for external battery supply

Used for connecting the PV 403 PEEP with BREAS external battery EB 2 or another 24 V DC power source. Read the operating manual thoroughly before using the battery connector, see page 23.

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Main components and panels

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Operating Manual PV 403 PEEP

No.

User controls and components

Function

7

Analog/Digital output connector

Used for connecting the PV 403 PEEP to a remote alarm, a PC, or other external equipment. Read the operating manual thoroughly before using the analog/digital connector, see page 68.

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Using the PV 403 PEEP

Using the PV 403 PEEP This chapter describes the basic procedure for operating the PV 403 PEEP. It is mainly intended for clinic personnel. Read the chapter “Safety precautions” on page 7 before setting up and using the PV 403 PEEP.

4.1

Installing the PV 403 PEEP When using the PV 403 PEEP for the first time, check the device for damage and to be sure that all ordered accessories are included according to the packing note or the invoice.

4.2

Placing the PV 403 PEEP Follow the instructions below for the placement of the PV 403 PEEP: • Do not use the PV 403 PEEP when exposed to direct sunlight.

4.3

•

Place the PV 403 PEEP on a solid, flat surface.

•

Make sure that nothing can block the filter cassette air inlet at the rear, right-hand side of the ventilator.

•

Check that the PV 403 PEEP cannot be affected by any electromagnetic fields emitted by other nearby equipment.

Connecting the patient circuit To connect the PV 403 PEEP to the patient circuit: 1 Connect the patient circuit to the patient air outlet on the front panel, see figure below. If a bacteria filter/oxygen adapter is used, connect it between the hose and the patient air outlet. 2 3 4

5

Connect the other end of the patient tube to the exhalation valve. Connect the thin white control tube to the exhalation valve connector (indicated by a white symbol) on the front panel. Connect the other end to the membrane nipple. Connect the green pressure sensor tube to the pressure measuring connector (indicated by a green symbol) on the front panel. Connect the other end to the pressure sensor nipple of the exhalation valve. Connect the exhalation valve to the flex tube. Connect the other end of the flex tube to the mask or the trachea cannula. Always follow the mask manufacturer’s instructions when applying a nasal mask.

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Using the PV 403 PEEP

Operating Manual PV 403 PEEP

To adjust the mask and patient circuit: 1 Adjust the mask straps so that it feels comfortable for the patient. 2

Route the patient circuit in a way convenient for the patient. Try different ways to find the best one. Do not strap the patient mask too tight. Start with loose straps and tighten as necessary to prevent leakage from the mask.

4.4

Connecting the PV 403 PEEP to the mains To connect the PV 403 PEEP: 1 Plug the power cord into the power socket of the PV 403 PEEP. 2 3

Connect the cord to the mains supply. Secure the power cord in the cable strain-relief clamp on the rear panel, to prevent that the power cord is accidentally disconnected.

The Power LED on the settings panel is lit when the PV 403 PEEP is connected to the mains. Make sure that the power cord is undamaged before it is connected to the machine. To isolate the PV 403 PEEP from the mains supply, remove the power cord.

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